DEVICES, SYSTEMS AND METHODS FOR EPICARDIAL CARDIAC MONITORING SYSTEM

• US 20100063375A1
• Filed: 01/22/2008
• Published: 03/11/2010
• Est. Priority Date: 01/22/2007
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. SR.
• Granted Patent: US 8,682,411 B2
• Time in Patent Office: Days
• US Class Current: 600/375
• CPC Class Codes: A61B 2560/066 catheters therefor
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/688 using adhesives
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

Devices, systems, and methods for remotely monitoring physiologic cardiovascular data are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for the delivery of the sensor to the epicardial surface of the heart. In addition, various disclosed embodiments provide for a memory device capable of receiving the physiologic cardiovascular data collected by the sensors and transmitting such data wirelessly to a remote location.

Claims

1. A portable monitoring system for monitoring the physiology of a heart, the portable monitoring system comprising:

a memory device for storing data; and

a sensory lead coupled with the memory device by at least a first connecting wire, the sensory lead comprising;

a connection assembly, and

at least one sensor for collecting physiologic data from an epicardial surface of a heart, the at least one sensor coupled with the connection assembly by a second connecting wire;

wherein the sensory lead is fully implantable within the chest cavity of a patient, and the memory device is capable of receiving the physiologic data collected by the at least one sensor through the first connecting wire.

2. The portable monitoring system of claim 1, wherein the connection assembly is further configured to traverse and seal an opening in the wall of a heart.

3. The portable monitoring system of claim 1, wherein the memory device is further capable of transmitting the physiologic data collected by the at least one sensor to a remote processor.

4. The portable monitoring system of claim 3, wherein the remote processor comprises a handheld device.

5. The portable monitoring system of claim 3, wherein the remote processor comprises a computer.

6. The portable monitoring system of claim 3, wherein the remote processor is configured to view the physiologic data.

7. The portable monitoring system of claim 3, wherein the remote processor is configured to process the physiologic data.

8. The portable monitoring system of claim 3, wherein the remote processor transmits the physiologic data to the remote processor over the interne.

9. The portable monitoring system of claim 3, wherein the memory device transmits the physiologic data to the remote processor using telemetry.

10. The portable monitoring system of claim 1, wherein the memory device is implantable beneath the skin of a patient.

11. The portable monitoring system of claim 1, wherein the at least one sensor further comprises an attachment mechanism for facilitating the attachment of the at least one sensor to an epicardial surface of a heart.

12. The portable monitoring system of claim 11, wherein the attachment mechanism comprises a pinching mechanism.

13. The portable monitoring system of claim 11, wherein the attachment mechanism comprises an adhesive mechanism and a suction mechanism.

14. The portable monitoring system of claim 11, wherein the attachment mechanism comprises an adhesive mechanism.

15. The portable monitoring system of claim 1, wherein the memory device is programmable.

16. The portable monitoring system of claim 15, wherein the memory device is capable of processing the physiologic data collected by the at least one sensor.

17. The portable monitoring system of claim 1, wherein the at least one sensor is selected from the group consisting of microtransducers, piezo crystals and pressure sensors.

18. The portable monitoring system of claim 1, wherein the opening is in the atrial wall of a heart.

19. The portable monitoring system of claim 1, wherein the opening is in the wall of the atrial appendage of a heart.

20. A sensor assembly for collecting physiologic data from a targeted tissue, the sensory assembly comprising:

a scaffold assembly having a body comprising a top portion, a bottom portion, and a first delivery channel, the bottom portion having a plurality openings therein and the first delivery channel in fluid communication with the plurality of openings in the bottom portion;

a delivery catheter, the delivery catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;

the first lumen comprising a second delivery channel in fluid communication with the first delivery channel of the scaffold assembly, and the second lumen comprising a wire channel in communication with the bottom portion of the scaffold assembly;

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor coupled within the body of the scaffold assembly; and

a connecting wire for transferring physiologic data collected by the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end encased within the wire channel of the delivery catheter;

wherein the first delivery channel of the scaffold assembly, the second delivery channel of the delivery catheter, and the number of openings in the bottom portion of the scaffold assembly are capable of allowing an adhesive substance to flow therethrough and onto the targeted tissue.

21. The sensory assembly of claim 20, wherein the scaffold assembly is comprised of a flexible material.

22. The sensory assembly of claim 21, wherein the scaffold assembly is capable of shifting between a first folded position comprising a first perimeter dimension and a second open position comprising a second perimeter dimension, wherein the first perimeter dimension is smaller than the second perimeter dimension.

23. The sensory assembly of claim 20, wherein the body of the scaffold assembly further comprises a plurality of magnetic beads embedded therein.

24. The sensory assembly of claim 20, wherein the body of the scaffold assembly surrounds the periphery of the at least one sensor.

25. The sensory assembly of claim 20, wherein the targeted tissue comprises an epicardial surface of a heart.

26. A method for attaching a sensory assembly to a surface of a targeted tissue comprising the steps of:

providing a sensor assembly comprising;

a scaffold assembly having a body comprising a top portion, a bottom portion, and a first delivery channel, the bottom portion having a plurality openings therein and the first delivery channel in fluid communication with the plurality of openings in the bottom portion,

a delivery catheter, the delivery catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;

the first lumen comprising a second delivery channel in fluid communication with the first delivery channel of the scaffold assembly, and the second lumen comprising a wire channel in communication with the bottom portion of the scaffold assembly,

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor coupled within the body of the scaffold assembly, and

a connecting wire for transferring physiologic data collected from the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end encased within the wire channel of the delivery catheter,

wherein the first delivery channel of the scaffold assembly, the second delivery channel of the delivery catheter, and the number of openings in the bottom portion of the scaffold assembly are capable of allowing an adhesive substance to flow therethrough and onto the targeted tissue;

positioning the at least one sensor of the sensor assembly on a targeted tissue surface;

inserting an adhesive into the second delivery channel of the delivery catheter; and

applying the adhesive to the targeted tissue surface by advancing the adhesive through the second delivery channel of the delivery catheter, the first delivery channel of the scaffold assembly, and through the plurality of openings in the bottom portion of the scaffold assembly; and

allowing the adhesive to adhere to the targeted tissue surface and the bottom portion of the scaffold assembly.

27. The method of claim 26, wherein the adhesive is selected from the group consisting of a ferromagnetic adhesive, a biological adhesive, and a nonbiological adhesive.

28. The method of claim 26, wherein the scaffold assembly is comprised of a flexible material and is capable of shifting between a first folded position comprising a first perimeter dimension and a second open position comprising a second perimeter dimension, wherein the first perimeter dimension is smaller than the second perimeter dimension, and wherein the step of positioning the at least one sensor of the sensor assembly on a targeted tissue surface further comprises the steps of:

shifting the scaffold assembly of the sensor assembly into the first folded position;

inserting the sensor assembly into a catheter comprising a proximal end and a distal end;

delivering the distal end of the catheter containing the sensor assembly via catheterization and percutaneous methods to the targeted tissue;

advancing the sensor assembly through the distal end of the catheter;

shifting the scaffold assembly of the sensor assembly into the second open position;

positioning the at least one sensor of the sensor assembly on the targeted tissue surface; and

withdrawing the catheter.

29. A sensor assembly for collecting physiologic data from a targeted tissue, the sensory assembly comprising:

a capsula having an exterior wall and a disk, the exterior wall comprising a flexible material and defining a closed end, an open end, and an interior space and the disk coupled with the closed end of the exterior wall;

a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the interior space of the capsula;

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk of the capsula such that the at least one sensor extends into the interior space of the capsula;

wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue.

30. The sensor assembly of claim 29, wherein the at least one sensor comprises an arrow-like or anchor-like shape.

31. The sensor assembly of claim 29, further comprising a connecting wire for transferring physiologic data collected by the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor and a proximal end extending through the open end of the capsula.

32. The sensor assembly of claim 29, wherein the exterior wall of the capsula is capable of shifting from a first upright position to a second collapsed position when a vacuum is maintained within the interior space of the capsula.

33. The sensor assembly of claim 29, wherein the at least one sensor further comprises an adhesive applied thereon.

34. A method for attaching a sensory assembly to a surface of a targeted tissue comprising the steps of:

providing a sensor assembly comprising;

a capsula having an exterior wall and a disk, the exterior wall comprising a flexible material and defining a closed end, an open end, and an interior space and the disk coupled with the closed end of the exterior wall,

a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the interior space of the capsula, and

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk of the capsula such that the at least one sensor extends into the interior space of the capsula,

wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue, and the exterior wall of the capsula is capable of shifting from a first upright position to a second collapsed position when suction is applied to the vacuum catheter;

positioning the sensor assembly proximate to a targeted tissue surface;

coupling the open end of the capsula with the targeted tissue surface by applying a suctional force to the proximal end of the vacuum catheter;

coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position;

ceasing the suctional force through the vacuum catheter;

uncoupling the at least one sensor from the disk of the capsula; and

withdrawing the sensor assembly.

35. The method of claim 34, wherein the at least one sensor of the sensor assembly comprises an arrow-like or anchor-like shape.

36. The method of claim 35, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position further comprises inserting the at least one sensor into the targeted tissue surface.

37. The method of claim 34, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position further comprises increasing the suctional force applied to the proximal end of the vacuum catheter.

38. The method of claim 34, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position further comprises the steps of:

applying an amount of adhesive to the at least one sensor; and

sandwiching the amount of adhesive on the at least one sensor between the sensor and the surface of the targeted tissue.

39. The method of claim 34, wherein the step of positioning the sensor assembly proximate to a targeted tissue surface further comprises the steps of:

inserting the sensor assembly into a catheter comprising a proximal end and a distal end;

delivering the distal end of the catheter containing the sensor assembly proximate to the targeted tissue surface through catheterization and percutaneous methods;

advancing the sensor assembly through the distal end of the catheter; and

withdrawing the catheter.

40. The method of claim 35, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position further comprises the steps of:

applying an amount of adhesive to the at least one sensor;

inserting the at least one sensor into the targeted tissue; and

sandwiching the amount of adhesive on the at least one sensor between the sensor and the targeted tissue.

41. A sensor assembly for collecting physiologic data from a targeted tissue, the sensory assembly comprising:

a capsula having an exterior wall, a disk, and a flexible membrane, the exterior wall defining a closed end, an open end, and an interior space, the disk coupled with the flexible membrane, and the flexible membrane extending through the interior space and defining an upper chamber between the flexible membrane and the closed end of the exterior wall and a lower chamber between the flexible membrane and the open end of the exterior wall;

a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the lower chamber of the capsula;

a delivery catheter having a proximal end and a distal end, the distal end of the delivery catheter coupled with the exterior wall of the capsula and in communication with the upper chamber of the capsula;

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk such that the at least one sensor extends into the lower chamber of the capsula;

wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue, and the flexible membrane is capable of shifting from a first upright position to a second collapsed position when a gas is introduced into the upper chamber through the delivery catheter and suction is applied to the vacuum catheter.

42. The sensor assembly of claim 41, wherein the at least one sensor comprises an arrow-like or anchor-like shape.

43. The sensor assembly of claim 41, further comprising a connecting wire for transferring physiologic data collected by the at least one sensor, the connecting wire comprising a distal end coupled with the at least one sensor, and a proximal end extending through the open end of the capsula.

44. The sensor assembly of claim 41, wherein the membrane of the capsula is capable of shifting from a first upright position to a second collapsed position when a vacuum is maintained within the lower chamber of the capsula and the pressure is increased in the upper chamber of the capsula.

45. The sensor assembly of claim 41, wherein the at least one sensor further comprises an adhesive applied thereon.

46. A method for attaching a sensory assembly to a surface of a targeted tissue comprising the steps of:

providing a sensor assembly comprising;

a capsula having an exterior wall, a disk, and a flexible membrane, the exterior wall defining a closed end, an open end, and an interior space, the disk coupled with the flexible membrane, and the flexible membrane extending through the interior space and defining an upper chamber between the flexible membrane and the closed end of the exterior wall and a lower chamber between the flexible membrane and the open end of the exterior wall,

a vacuum catheter having a proximal end and a distal end, the distal end of the vacuum catheter coupled with the exterior wall of the capsula and in communication with the lower chamber of the capsula,

a delivery catheter having a proximal end and a distal end, the distal end of the delivery catheter coupled with the exterior wall of the capsula and in communication with the upper chamber of the capsula,

at least one sensor capable of collecting physiologic data from a targeted tissue, the at least one sensor removably coupled with the disk such that the at least one sensor extends into the lower chamber of the capsula,

wherein the open end of the capsula is configured to removably attach to a targeted tissue such that the application of suction to the vacuum catheter is capable of forming a reversible seal with the targeted tissue, and the flexible membrane is capable of shifting from a first upright position to a second collapsed position when a gas is introduced into the upper chamber through the delivery catheter and suction is applied to the vacuum catheter;

positioning the sensor assembly proximate to a targeted tissue surface;

coupling the open end of the capsula with the targeted tissue surface by applying a suctional force to the proximal end of the vacuum catheter;

introducing a gas into the upper chamber of the capsula through the delivery catheter;

coupling the at least one sensor with the surface of the targeted tissue surface by shifting the flexible membrane of the capsula to the second collapsed position;

ceasing the suctional force through the vacuum catheter and the introduction of the gas through the delivery catheter;

uncoupling the at least one sensor from the disk of the capsula; and

withdrawing the sensor assembly.

47. The method of claim 46, wherein the at least one sensor of the sensor assembly comprises an arrow-like or anchor-like shape.

48. The method of claim 47, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the flexible membrane of the capsula to the second collapsed position further comprises inserting the at least one sensor into the targeted tissue surface.

49. The method of claim 46, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the flexible membrane of the capsula to the second collapsed position further comprises increasing the suctional force applied to the proximal end of the vacuum catheter and increasing the amount of gas introduced through the delivery catheter, such that a downward force is applied to the flexible membrane.

50. The method of claim 46, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the flexible membrane of the capsula to the second collapsed position further comprises the steps of:

applying an amount of adhesive to the at least one sensor; and

allowing the adhesive to adhere to the at least one sensor and to the surface of the targeted tissue.

51. The method of claim 46, wherein the step of positioning the sensor assembly proximate to a targeted tissue surface further comprises the steps of:

inserting the sensor assembly into a catheter comprising a proximal end and a distal end;

delivering the distal end of the catheter containing the sensor assembly proximate to the targeted tissue via catheterization and percutaneous methods;

advancing the sensor assembly through the distal end of the catheter; and

withdrawing the catheter.

52. The method of claim 47, wherein the step of coupling the at least one sensor with the surface of the targeted tissue surface by shifting the exterior wall of the capsula to the second collapsed position further comprises the steps of:

applying an amount of adhesive to the at least one sensor;

inserting the at least one sensor into the targeted tissue surface; and

allowing the adhesive to adhere to the at least one sensor and to the targeted tissue.

53. A method of delivering a monitoring system to a heart, the method comprising the steps of:

providing a system comprising;

an engagement catheter comprising a proximal end, a distal end and first and second lumens extending between the proximal end and the distal end;

a first delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the first delivery catheter configured to be inserted into the second lumen of the engagement catheter;

a needle located at the distal end of the first delivery catheter; and

a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to the vacuum source;

a second delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the second delivery catheter configured to be inserted into the second lumen of the engagement catheter;

a monitoring system comprising;

a memory device for storing data, and

a sensory lead coupled with the memory device by at least a first connecting wire and positioned within the distal end of the second delivery catheter, the sensory lead comprising;

a connection assembly configured to traverse an opening in a wall of a heart, and

at least one sensor for collecting physiologic data from an epicardial surface of a heart, the at least one sensor coupled with the connection assembly by a second connecting wire,

wherein the sensory lead is fully implantable within the chest cavity of a patient, and the memory device is capable of receiving the physiologic data collected by the at least one sensor through the first connecting wire,

wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and

wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds a heart by retracting the targeted tissue away from the pericardial sac;

inserting the engagement catheter into the body such that the distal end of the engagement catheter is positioned inside the heart and the suction port is in contact with the targeted tissue on the interior of the wall of the heart;

operatively connecting a vacuum source to the vacuum port such that the suction port is reversibly attached to the targeted tissue on the interior of the wall of the heart;

inserting the first delivery catheter into the second lumen of the engagement catheter;

piercing the targeted tissue on the interior of a wall of the heart with the needle, thereby forming an opening in the wall of the heart;

accessing the pericardial space by inserting a guide wire through the wall of the heart into the pericardial space;

withdrawing the first delivery catheter from the second lumen of the engagement catheter;

inserting the second delivery catheter into the second lumen of the engagement catheter;

advancing the distal end of the second delivery catheter into the pericardial space;

delivering the at least one sensor of the sensory lead into the pericardial space and coupling the at least one sensor with an epicardial surface of the heart;

withdrawing the second delivery catheter into the interior of the heart;

delivering the connection assembly of the sensory lead into the opening in the wall of the heart, thereby sealing the opening;

removing the second delivery catheter from the engagement catheter; and

implanting the memory device under the skin of the body.

54. The method of claim 54, wherein the targeted tissue comprises a portion of an atrial wall.

55. The method of claim 54, wherein the targeted tissue comprises a portion of an atrial appendage.

56. A method of delivering a monitoring system to a heart, the method comprising the steps of:

extending into a blood vessel an elongated tube having a proximal end, a distal end, and at least one lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of the wall of the heart;

aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart;

accessing the pericardial space by puncturing the wall of the heart;

delivering at least one sensor to the pericardial space;

coupling the at least one sensor to the epicardial surface of the heart; and

removing the elongated tube from the body.

57. The method of claim 56, wherein the step of accessing the pericardial space by puncturing the wall of the heart comprises:

inserting through one of the at least one lumen of the elongated tube a delivery catheter having a proximal end, a distal end, and a needle located at the distal end, such that the needle is located within the heart;

inserting the needle into the targeted tissue; and

withdrawing the needle from the targeted tissue.

58. The method of claim 56, wherein the step of delivering at least one sensor to the pericardial space comprises:

providing a delivery catheter having a distal end and a proximal end;

providing a monitoring system located in the distal end of the delivery catheter; and

inserting the distal end of the delivery catheter into the pericardial space.